[Translation] A single-center, randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of single and multiple doses of PTT-621 in healthy Chinese volunteers
主要目的:评价PTT-621在健康受试者中单、多次不同剂量给药后的安全性和耐受性。 次要目的:评价PTT-621在健康受试者中单、多次不同剂量给药后的药代动力学(Pharmacokinetics,PK)特征。 探索性目的:1)探索PTT-621在健康受试者中单、多次不同剂量给药后体内生物标志物浓度变化特征;2)评价PTT-621在健康受试者中单次不同剂量给药后的血药浓度对QTc间期的影响(C-QTc研究);3)探索食物对PTT-621药代动力学特征的影响。
[Translation] Primary objective: To evaluate the safety and tolerability of PTT-621 after single and multiple administrations of different doses in healthy subjects. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of PTT-621 after single and multiple administrations of different doses in healthy subjects. Exploratory objectives: 1) To explore the characteristics of changes in biomarker concentrations in vivo after single and multiple administrations of different doses of PTT-621 in healthy subjects; 2) To evaluate the effect of blood drug concentrations of PTT-621 on the QTc interval after single and multiple administrations of different doses in healthy subjects (C-QTc study); 3) To explore the effect of food on the pharmacokinetic characteristics of PTT-621.